CalciMedica Announces FDA Alignment on Phase 2b Trial Design for Auxora in Acute Pancreatitis and Identifies Disease's First Potential Registrational Endpoints

Phase 2AuxoraPositive

AI Analysis

Summary

CalciMedica announced FDA alignment on the Phase 2b trial design for Auxora in acute pancreatitis, with new-onset severe respiratory failure as the primary endpoint and identification of disease's first potential registrational endpoints. The FDA also aligned on elevated LDH as a potential enrichment marker strategy.

Clinical Trial Data

Phase

Phase 2b

Outcome Details

FDA alignment on Phase 2b trial design with new-onset severe respiratory failure as primary endpoint; multi-organ failure and time to medically indicated discharge as key secondary endpoints; elevated LDH evaluated as potential enrichment marker

Importance:6/10

Sentiment:

0.60

FDA alignmentPhase 2b trial designacute pancreatitisregistrational endpointsenrichment marker

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$CALC

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Published by PR Newswire Biotech on July 29, 2026 11:00 AM

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